E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10060848 |
E.1.2 | Term | Ischemic cerebral infarction |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
Évaluer la capacité du [18F]DPA-714 à localiser et quantifier la densité en protéine translocatrice TSPO, exprimée lors de l’activation microgliale, dans l’Infarctus Cérébral |
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E.2.2 | Secondary objectives of the trial |
Comparer les taux de recouvrement des territoires d’infarctus IRM / DPA714 et IRM / PK11195 décrits dans la littérature. Evaluer la sécurité d’utilisation du [18F]DPA-714 |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Homme ou femme - Age : entre 18 et 85 ans - Infarctus Cérébral récent (diagnostic par TDM ou IRM) : entre J6 et J20 - Territoire: ACM gauche ou droite - Patients non thrombolysés - Signature du consentement éclairé - Affiliation au régime de sécurité sociale
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E.4 | Principal exclusion criteria |
- Participation à une autre étude clinique concomitante ou au cours du mois précédent l’inclusion. - Pathologies évolutives non équilibrées : vasculaires, cardiaques, cancer, gammapathie monoclonale maligne - Antécédents psychiatriques majeurs - Femme enceinte ou en période d’allaitement ou en âge de procréer sans méthode contraceptive - Contre-indication à l’IRM - Prise de traitement anti-inflammatoire (AINS) ou corticoïde au long cours
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E.5 End points |
E.5.1 | Primary end point(s) |
Potentiel de liaison (PL) du [18F]DPA-714 dans les régions d’intérêt sélectionnées dans le cortex cérébral et dans les régions symétriques de l'hémisphère controlatéral. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Yes |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | Information not present in EudraCT |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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date de la dernière visite du dernier patient participant au terme des 2 ans d'inclusion |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |